Roundtable Discussion Method Validation & Verification
|
|
- Brittany McLaughlin
- 6 years ago
- Views:
Transcription
1 Roundtable Discussion Method Validation & Verification 2 May 2016 DeAnn Benesh 3M All Rights Reserved
2 WHAT is Validation? Reference Codex CAC/GL 74 1 ISO USDA FSIS 3 US FDA 4 Validation Definition Process to establish the performance characteristics and limitations of an analytical method: which analytes, in what kind of matrices, in the presence of which interference. Result = precision and trueness values of a certain analytical method under the examined conditions. 1 [pg 2] Establishment of the performance characteristics of a method and provision of objective evidence that the performance requirements for a specified intended use are fulfilled. 2 [pg 2] Process to measure performance characteristics of a particular test, with the goal of determining whether the test is equivalent to the reference test for the intended conditions of use. Equivalent = the performance characteristics are statistically indistinguishable. 3 [pg 2] Demonstration that adequate confidence is provided when the results obtained by the alternative method i.e. the commercially available kit, are comparable to or exceed those obtained using the reference method using the statistical criteria contained in the approved validation protocol. 4 [pg 16] ISO The confirmation by examination and the provision of objective evidence that the 17025: particular requirements for a specific intended use are fulfilled. 6 3M All Rights Reserved 2
3 Summary of ALL Validation reference definitions: Validation: 1. Performance characteristics are defined, then 2. compared to a reference method, and then 3. statistically evaluated to determine equivalence A method is validated for the matrices [& sample sizes] included in the validation 3M All Rights Reserved 3
4 Categories of Microbiological Test Methods Performance Characteristics Included in a Validation Study 1 Performance Characteristic Quantitative Qualitative (presence/absence) Relative Accuracy (% Recovery) Yes No Matrix Effects Yes Yes Precision Yes No Sensitivity Yes Yes Specificity Yes Yes Inclusivity Yes Yes Exclusivity Yes Yes False Positive Rate Yes Yes False Negative Rate Yes Yes LOD [POD or LOD50] Yes Yes LOQ Yes No Ruggedness Yes Yes Linearity/Range Yes No Dr. Michael Brodsky AOAC International 2013 Annual Meeting 3M All Rights Reserved
5 Methods requiring validation: New or original methods Modifications to validated methods Extension of scope to include additional analytes, matrices, or changes in intended use Changes involving new technology or automation Significant parameter changes: reagents/apparatus, time /temperature incubation periods, enrichment media, etc. It is possible that small changes/matrix extensions to a related product etc would not need a full validation but may need some level of testing to assess for unintended differences. 3M All Rights Reserved
6 WHY are Validated methods important? Validated methods are required for conducting Official Testing Official = adjective, relating to an authority or public body and its activities and responsibilities [Oxford online dictionary] European Union regulations specifically stipulate validated methods that have been collaboratively studied Internationally, regulatory agencies require, or at least prefer, to use methods that have been validated and collaboratively studied. Some global regulatory agencies require AOAC Official Methods of Analysis to receive Final Action, before they may be used as an Official method 3M All Rights Reserved
7 REQUIREMENTS of methods for Official use Agency Codex CAC/GL 21 8 (EC) No Method Validation Requirements Whenever possible, only methods for which the reliability (accuracy, reproducibility, inter- and intra-laboratory variation) has been statistically established in comparative or collaborative studies in several laboratories should be used. The use of alternative analytical methods is acceptable when the methods are validated 2073/ against the reference method in Annex I and if a proprietary method, certified by a third party in accordance with the protocol set out in EN/ISO standard or other internationally accepted similar protocols, is used. Pg 9 USDA FSIS 11 US FDA 4 All analytical methods described in FSIS-MLG have been scientifically validated and are considered fit for their intended purpose. Laboratories may also use other validated testing methods that differ from the methods described in FSIS-MLG. For the intended conditions of use, the performance characteristics of the new method and the well characterized method should be statistically indistinguishable Pg 13 FDA-BAM presents the agency's preferred laboratory procedures for microbiological analyses of foods and cosmetics. Methods fully validated in a collaborative study monitored and evaluated by an independent accrediting body e.g. AOAC-OMA, AFNOR, etc. require in-house verification for the first use 3M All Rights Reserved 7
8 What is considered an OFFICIAL method? Official Methods = Methods used or accepted for use by a regulatory authority Traditional, cultural methods [may be jurisdiction specific] ISO Method ISO Validated Methods AOAC Official Methods FDA Bacteriological Analytical Methods USDA FSIS Microbiology Laboratory Methods HC Compendium of Analytical Methods, Volumes 1 to 5 Any of the above methods MAY be accepted for use by regulatory agencies, IF: They have been compared to an acceptable reference method They have been validated as fit for purpose for the matrices analyzed 3M All Rights Reserved 8
9 Validation Schemes ISO AFNOR: French National Organization for Standardization MicroVal: European certification body for microbiology methods NordVal: Nordic certification body: Denmark, Finland, Iceland, Norway and Sweden AOAC Research Institute [RI]: International Standards Organization Performance Tested Method (PTM) Official Method of Analysis (OMA) 3M All Rights Reserved 9
10 AFNOR and MicroVal Certification schemes based on EN/ISO 16140: Comparison Study to reference method 1. Independent expert laboratory co-ordinates validation 2. Inter-laboratory study [collaborative study] 3. All Foods Claim Regular audit of the quality system of the manufacturer [based on EN standard (ISO 9002)] Regular verification of the certified methods post certification [every 4 years] 3M All Rights Reserved
11 AOAC Research Institute AOAC Performance Tested Method [PTM] Pre-collaborative + 1 Independent lab: I/E; Ruggedness testing, paper review of quality system. Yearly renewal paper process only NO all foods claim only for matrices evaluated AOAC PTM / Official Method of Analysis [OMA] Harmonization Complete AOAC PTM program / Initiate collaborative study to achieve OMA First Action status; Final Action status after 2 yrs use in the industry without issue AOAC PTM / OMA/ MicroVal Harmonization Both programs run simultaneously 1 collaborative study 3M All Rights Reserved
12 Method Scheme Websites list validated methods including claimed matrices, sample sizes AFNOR MicroVal AOAC 5a-1f6d-4d78-a498-19b9763d11b4&hkey=33b744f6-f71e-456a &CCO=5 NordVal 3M All Rights Reserved 12
13 Comparison of VERIFICATION definitions Reference Codex ISO USDA FSIS US FDA ISO 17025:2005 Verification Definition Could not find a method verification definition Codex documents [only process verification] Demonstration that a validated method functions in the user's hands according to the method's specifications determined in the validation study and is fit for purpose Laboratory should demonstrate on-going competence in performing the method at their facility, which would include participating in proficiency test programs 11 Pg 13 The confirmation by examination and the provision of objective evidence that specified requirements have been fulfilled. 4 Pg 16 The Laboratory shall confirm that it can properly operate standard methods before introducing the tests or calibrations 3M All Rights Reserved 13
14 Verification for USE Proof that the laboratory can perform the [validated] method as intended This applies only to matrices and sample sizes that were included in the validation study FDA has detailed Guidance on in-house verification of a validated method before use 4 Pg 16 3M All Rights Reserved 14
15 Distinguishing Validation and Verification Validation Demonstrate the METHOD is equivalent to the reference method [for the matrices validated] based on defined method criteria Verification Demonstrate in the hands of the USER that the method can be performed to meet the defined method criteria 3M All Rights Reserved 15
16 Categories of Microbiological Test Methods Performance Characteristics Included in the Verification of a Validated Method 1 Performance Characteristic VALIDATION Quantitative VALIDATION Qualitative (P/A) VERIFICATION (Where Applicable) Relative Accuracy (% Recovery) Yes No Yes Matrix Effects Yes Yes Yes Precision Yes No Yes Sensitivity Yes Yes Yes Specificity Yes Yes Yes Inclusivity Yes Yes No Exclusivity Yes Yes No False Positive Rate Yes Yes Yes False Negative Rate Yes Yes Yes LOD [POD or LOD50] Yes Yes No LOQ Yes No No Ruggedness Yes Yes No Linearity/Range Yes No No Dr. Michael Brodsky AOAC International 2013 Annual Meeting 3M All Rights Reserved
17 CONTINOUS Verification - ISO requirement Proficiency Testing: Should be done several times per year Should be handled as a routine sample not specially handled Can help determine the performance of individual laboratories for specific tests Is used to monitor laboratories continuing performance Can demonstrate an analyst s ability to properly perform the test Test samples: Certified proficiency test providers Internal Ring tests 3M All Rights Reserved 17
18 ISO Update 3M All Rights Reserved
19 ISO 16140: Six Parts Part 1: Definitions Part 2: Protocol to compare REFERENCE vs ALTERNATIVE method Part 3: Verification Part 4: Single Lab Validation Part 5: Use of Factorial Design for Collaborative Study Part 6: Confirmation 3M All Rights Reserved
20 ISO Verification Still Drafting so do NOT share this information! Current Timeline: Drafting Group (DG) meeting held in UK, first week of April Co-chairs will meet in July to summarize and work on FINAL DRAFT Send to Working Group (WG) 3 for review & comments OCT-NOV WG 3 Meeting 3M in US for final discussion Sent for SC9 Review prior to ISO SC9 Plenary Meeting in May/June M All Rights Reserved 20
21 ISO IMPLEMENTATION Verification Demonstrate competence to perform the validated method Applies only to methods with published validation data (reference or alternative methods). Test 1 sample Type used in the validation, applicable to the user lab Sample TYPE Verification Demonstrate competence to perform the method with sample TYPES routinely tested in the user lab Select sample TYPES from the CATEGORIES included in the scope of the validated method, but not tested in the validation study 3M All Rights Reserved 21
22 ISO IMPLEMENTATION Verification Sample TYPE Method ITEM Reference method w/published data Validated alternative method 1 relevant ITEM from the TYPES tested in the validation study Reference method with or without data Validated alternative method ITEMS from the TYPES included in the scope of the method, not tested in the validation and relevant to the user laboratory 3M All Rights Reserved 22
23 ISO Table A. 1: Classification of sample types & suggested target combinations for validation studies CATEGORIES Raw Milk & Dairy Products Heat Processed Milk & Dairy Products Raw meat & Ready-to-cook meat products (except poultry) Ready-to-eat, ready-to-reheat meat products Raw Poultry & ready-to-cook poultry products Ready-to-eat, ready-to-reheat meat poultry products Eggs & egg products (derivatives) Raw & ready-tocook fish & seafoods (unprocessed Ready-to-eat, ready-to-reheat fishery products Fresh produce & fruits Processed fruits & vegetables Dried cereals, fruits, nuts, seeds and vegetables Infant formula & infant cereals Chocolate, bakery products & confectionary Multicomponent foods or meal components Primary production samples Pet food & animal feed Environmental samples (food or feed production There are 18 CATEGORIES recognized and harmonized between ISO and AOAC 3M All Rights Reserved 23
24 ISO Verification (TYPE) CATEGORIES TYPES ITEMS Raw Meat & Readyto-Cook meat products (except poultry) Ready-to-eat, Ready-to-reheat meat products Fresh meats (unprocessed) Read-to-cook (processed) Cooked meat products Fermented or dried meat products Raw cured (smoked Aw >0.92) Raw cured (smoked Aw <0.92) Canned meat (ambient stable) Carcasses, meat cuts, Carpaccio s Minced meat, meat preparation, Carpaccio s Carcasses, swabs, rinsates Frozen burger patties, marinated beef shish-kababs Cooked ham, pate Salami Filet de sax, lard Cobourg ham, dry cured ham Corned beef There are 82 sample TYPES listed under the 18 categories 3M All Rights Reserved 24
25 ISO Data Analysis DG 3 met with DG 2 (statistics) in April to work on study design Still drafting, but will be based on Bias Natural contamination preferred to inoculated Determine L, M, H levels Compare results to published data to determine acceptibility 3M All Rights Reserved 25
26 3M All Rights Reserved
27 References 1. CODEX - CAC/GL Guidelines on performance criteria and validation of methods for detection, identification and quantification of specific dna sequences and specific proteins in foods 2. ISO/DIS Microbiology of food and animal feed Method validation Part 1: Vocabulary Currently under revision 3. USDA FSIS: Guidance for Test Kit Manufacturers, Laboratories: Evaluating the Performance of Pathogen Test Kit Methods 4. US FDA: Guidelines for the Validation of Analytical Methods for the Detection of Microbial Pathogens in Foods 5. ISO 17025:2005 General requirements for the competence of testing and calibration laboratories NO LINK, this is copyrighted material AOAC International Annual Meeting presentation, with permission from: Michael Brodsky, President, Brodsky Consultants, Thornhill, Ontario, Canada mhbrodsky@rogers.com 7. CODEX CAC/GL Principles for the Establishment and Application of Microbiological Criteria for Foods 8. COMMISSION REGULATION (EC) No 2073/2005 of 15 November 2005 on microbiological criteria for foodstuffs : 9. Health Products and Food Branch (HPFB) Standards and Guidelines for Microbiological Safety of Food - An Interpretive Summary 6. Equivalent Methods USDA FSIS: Establishment Guidance for the Selection of a Commercial or Private Microbiological Testing Laboratory: AOAC: AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Microbiological Methods for Food and Environmental Surfaces Official Methods for the Microbiological Analysis of Foods 3M All Rights Reserved 27
A2LA. R231 Specific Requirements: Threat Agent Testing Laboratory Accreditation Program. December 6, 2017
Laboratory Page 1 of 17 Laboratory December 6, 2017 2017 by A2LA All rights reserved. No part of this document may be reproduced in any form or by any means without the prior written permission of A2LA.
More informationEU Regulation on Microbiological Criteria for Foodstuffs. Mary Howell Hygiene and Microbiology UK Food Standards Agency
EU Regulation on Microbiological Criteria for Foodstuffs Mary Howell Hygiene and Microbiology UK Food Standards Agency import production processing distribution preparation consumption Importers Agro-chemical
More informationMicrobiological criteria and shelf-life. ...Current legal situation
Microbiological criteria and shelf-life...current legal situation Dr. Mary Friel Technical Executive, FSAI Commission Regulation (EC) No 2073/2005 on Microbiological Criteria for Foodstuffs Entered into
More informationUpdate on activities in ISO and CEN. Kirsten Mooijman
Update on activities in ISO and CEN Kirsten Mooijman Relevant groups in ISO and CEN ISO/TC34/SC9: ISO: International Standardisation Organisation TC34: Technical Committee 34 on Food products SC9: Subcommittee
More informationGuidance Document for Sampling and Lotting of Beef Products and Sample Analysis for Pathogens Developed by the Beef Industry Food Safety Council
Guidance Document for Sampling and Lotting of Beef Products and Sample Analysis for Pathogens Developed by the Beef Industry Food Safety Council Developed by members of the Beef Industry Food Safety Council
More informationI EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Ref. Ares(2014)2013769-19/06/2014 I EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) 2013-7244 FINAL MICROBIOLOGICAL CRITERIA FOR FOOD OVERVIEW
More informationResults in 24 hours! AFNOR Certificate TRA 02/08-03/01 NordVal Ref nr. 001
T AOAC Performance Tested Method 010602 AFNOR Certificate TRA 02/08-03/01 NordVal Ref nr. 001 Approved for all foods, feed products and environmental samples Matrices Tested: Animal Feeds Dairy Products
More informationLaboratory Procedure June 2003 HEALTH PRODUCTS AND FOOD BRANCH OTTAWA
Government of Canada Gouvernement du Canada Laboratory Procedure MFLP-28 June 2003 HEALTH PRODUCTS AND FOOD BRANCH OTTAWA THE QUALICON BAX SYSTEM METHOD FOR THE DETECTION OF LISTERIA MONOCYTOGENES IN A
More informationAPLAC GUIDELINES FOR FOOD TESTING LABORATORIES
APLAC GUIDELINES FOR FOOD TESTING LABORATORIES Issue No. 2 Issue Date: 01/08 Page 1 of 13 PURPOSE This document provides guidance to APLAC members and their accredited laboratories on the operation of
More informationAnnex to declaration of accreditation (scope of accreditation) Normative document: EN ISO/IEC 17065:2012 Registration number: C 412
Voluntary withdrawal for the crossed out activities as 15-02-2018 Location(s) where activities are performed under accreditation Head Office Meeuwenlaan 4-6 8011 BZ Zwolle The Netherlands Plot No C-113
More informationThe future of food testing which way to go?
The future of food testing which way to go? Franz Ulberth European Commission, DG Joint Research Centre, Institute for Reference Materials and Measurements (IRMM) http://irmm.jrc.ec.europa.eu The Joint
More informationRequirements for Selling Manufactured or Processed Foods At Farmers Markets and Other Direct-to-Consumer Markets
Attachment A Requirements for Selling Manufactured or Processed Foods At Farmers Markets and Other Direct-to-Consumer Markets Revised October 2015 SC Department of Health and Environmental Control In cooperation
More informationAOAC Official Methods of Analysis SM. Darryl Sullivan, Covance Laboratories and Past President, AOAC INTERNATIONAL
AOAC Official Methods of Analysis SM Darryl Sullivan, Covance Laboratories and Past President, AOAC INTERNATIONAL On March 28, 2011, the AOAC INTERNATIONAL Board of Directors approved an alternative path
More informationHPP Safety Validations: a Key Element for the Production of Innovative Dips and Wet Salads. October 17, 2016 Lincoln, NE
HPP Safety Validations: a Key Element for the Production of Innovative Dips and Wet Salads October 17, 2016 Lincoln, NE PhD. Jessie Usaga Visiting Associate Professor, Cornell University Associate Professor,
More informationMinimise risk. Maximise competitive edge.
Minimise risk. Maximise competitive edge. Innovative food and environmental safety solutions optimised for your unique needs It s time to put your pathogen testing to the test When the world s biggest
More informationPRECISE AND POWERFUL MOLECULAR PATHOGEN DETECTION
PRECISE AND POWERFUL MOLECULAR PATHOGEN DETECTION RAPID FOOD SAFETY YOU CAN RELY ON Food companies, service labs and government regulators around the world rely on the Hygiena BAX System, which uses the
More informationPRINCIPLES FOR THE USE OF SAMPLING AND TESTING IN INTERNATIONAL FOOD TRADE CAC/GL Adopted in Revision: 2015.
PRINCIPLES FOR THE USE OF SAMPLING AND TESTING IN INTERNATIONAL FOOD TRADE CAC/GL 83-2013 Adopted in 2013. Revision: 2015. CAC/GL 83-2013 2 1. INTRODUCTION Sampling and testing are, among others, procedures
More informationSCOPE OF ACCREDITATION TO ISO/IEC 17025:2005. COVANCE LABORATORIES INC Wright St Madison, WI Hollis Cloninger Phone:
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 COVANCE LABORATORIES INC. 2102 Wright St Madison, WI 53704 Hollis Cloninger Phone: 608 210-5501 BIOLOGICAL Valid To: November 30, 2017 Certificate Number: 2918.05
More informationUncertainties and certainties in GMO analytics using qpcr
Uncertainties and certainties in GMO analytics using qpcr PD Dr. Philipp Hübner Kantonales Labor Basel-Stadt Abteilung Lebensmittel Postfach CH-412 Basel using qpcr historical review Short crash course
More informationRAPID Salmonella. RAPID Salmonella. Ref# Description Pre-poured mm x 20 dishes mm x 120 dishes
Ref# Description Pre-poured 3563961 90 mm x 20 dishes 3563963 90 mm x 120 dishes Dehydrated 3564705 500g FIELD OF APPLICATION is a chromogenic medium used for the detection of Salmonella spp. in the analysis
More information- CONTAMINANTS IN FOOD (COUNCIL REGULATION (EEC) No 315/93 OF 8 FEBRUARY 1993 LAYING DOWN COMMUNITY PROCEDURES FOR CONTAMINANTS IN FOOD 1 )
REPORT ON THE RELATIONSHIP BETWEEN ANALYTICAL RESULTS, MEASUREMENT UNCERTAINTY, RECOVERY FACTORS AND THE PROVISIONS OF EU FOOD AND FEED LEGISLATION, WITH PARTICULAR REFERENCE TO COMMUNITY LEGISLATION CONCERNING
More informationTECHNICAL GUIDANCE FOR THE VALIDATION OF METHODS USED BY CHEMICAL LABORATORIES IN THE FOOD, WATER AND RELATED INDUSTRIES
TECHNICAL GUIDANCE FOR THE VALIDATION OF METHODS USED BY CHEMICAL LABORATORIES IN THE FOOD, WATER AND RELATED INDUSTRIES Approved By: Chief Executive Officer: Ron Josias Senior Manager: Christinah Leballo
More informationA European Food Prices Monitoring Tool
EUROPEAN COMMISSION EUROSTAT Directorate G: Business Statistics Unit G-6: Price statistics Luxembourg, October 2009 A European Food Prices Monitoring Tool A first design A European Food Prices Monitoring
More informationSpecial aspects of European Ordinances regarding Cleaning and Disinfection in Food Premises
Module 6 Special aspects of European Ordinances regarding Cleaning and Disinfection in Food Premises This project has been funded with support from the European Commission. This publication [communication]
More informationISO and food. Great things happen when the world agrees.
ISO and food Great things happen when the world agrees. We are ISO, the International Organization for Standardization We are an independent, non-governmental organization. We are a global network of
More informationPART III - EI PROCESSING OF ANIMAL PERISHABLE PRODUCTS
GFSI BENCHMARKING REQUIREMENTS GFSI Guidance Document Version 7 PART III - EI PROCESSING OF ANIMAL PERISHABLE PRODUCTS PART III - EI PROCESSING OF ANIMAL PERISHABLE PRODUCTS Scheme Scope and Key Elements
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
Accredited to ISO/IEC 17021-1:2015 to provide Food Safety Unit 23 Hanborough Business Park Long Hanborough Oxford OX29 8SJ Contact: Mrs E Matthee Tel: +44 (0)1993 885600 Fax: +44 (0)1993 885603 Email:
More informationCERTIFICATE OF ACCREDITATION
CERTIFICATE OF ACCREDITATION ANSI-ASQ National Accreditation Board/ACLASS 500 Montgomery Street, Suite 625, Alexandria, VA 22314, 877-344-3044 This is to certify that Molecular Epidemiology, Inc. (MEI)
More informationECONOMIC BULLETIN Q2 2017
November 2017 ECONOMIC BULLETIN Q2 2017 Steady growth in production, sales and exports Food and drink industry Growth in production and sales In Q2 2017, EU food and drink industry production increased
More informationFapas GM (GeMMA) Proficiency Testing Programme 2017
Fapas GM (GeMMA) Proficiency Testing Programme 2017 Contents Who We Are 3 Fapas Proficiency Tests 4 Mixed Event Unprocessed Matrix (MU) 6 Mixed Event Processed Matrix (MP) 6 Single Event Tobacco Matrix
More informationEUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL
Ref. Ares(2013)2971942-03/09/2013 EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate F - Food and Veterinary Office DG(SANCO) 2013-6861 - MR FINAL FINAL REPORT OF AN AUDIT CARRIED
More informationINDUSTRY INFORMATION SESSION Agenda
INDUSTRY INFORMATION SESSION 2012 Agenda Food Safety Enhancement Program (FSEP) update Validation of control measures HACCP system maintenance & reassessment Action plan CFIA verification of FSEP recognized
More informationFood safety at Nestlé: combining foresight, vigilance and harmonised standards
Food safety at Nestlé: combining foresight, vigilance and harmonised standards John O Brien Head, Food Safety and Quality, Nestlé Research Centre Disclaimer This presentation contains forward looking statements
More informationTerms and conditions for laboratories appointed to undertake the testing of compost under the Compost Certification Scheme aligned to PAS 100 and the
Terms and conditions for laboratories appointed to undertake the testing of compost under the Compost Certification Scheme aligned to PAS 100 and the Compost Quality Protocol Renewable Energy Assurance
More informationFapas GM Proficiency Testing Programme 2018/2019
Fapas GM Proficiency Testing Programme 2018/2019 Contents Who We Are 3 Fapas Proficiency Tests 4 Mixed Event Matrix Combinations (MC) 5 Mixed Event Unprocessed Matrix (MU) 6 Mixed Event Processed Matrix
More informationPublic Health Microbiology Lab. Cork Integrated Service Area(ISA), HSE South
Public Health Microbiology Lab. Cork Integrated Service Area(ISA), HSE South St. Finbarr s Hospital, Douglas Road, Cork Testing Laboratory Registration number: 087T is accredited by the Irish National
More informationvalidation report for TaqMan Roundup Ready Quantification Kit
validation report for TaqMan Roundup Ready Quantification Kit Life Technologies offers a breadth of products DNA RNA protein cell culture instruments For Research Use Only. Not intended for any animal
More informationPublic Health Microbiology Lab. Cork Integrated Service Area(ISA), HSE South
Public Health Microbiology Lab. Cork Integrated Service Area(ISA), HSE South St. Finbarr s Hospital, Douglas Road, Cork Testing Laboratory Registration number: 087T is accredited by the Irish National
More informationA24 CALA Checklist for Microbiology Revision 4.1 February 16, 2018
A24 CALA Checklist for Microbiology Revision 4.1 February 16, 2018 Laboratory Name: Appendix Name: Appendix Number: Assessor: Date: Rev. 4.1 CALA CHECKLIST FOR MICROBIOLOGY Item 01 SAMPLING AND SAMPLE
More informationTable of Contents Page
COMPLIANCE GUIDELINES TO CONTROL LISTERIA MONOCYTOGENES IN POST-LETHALITY EXPOSED READY-TO-EAT MEAT AND POULTRY PRODUCTS Summary of Guidance Material Table of Contents Page 3 A. Introduction 4 B. Control
More informationGuidance Document. Meeting Requirements as a Registered Food Importer. A guidance document issued by the Ministry for Primary Industries
Guidance Document Meeting Requirements as a Registered Food Importer. 23 February 2016 A guidance document issued by the Ministry for Primary Industries Title Meeting Requirements as a Registered Food
More informationIFSQN Validation Blog References January 2015
(1) Codex GUIDELINES FOR THE VALIDATION OF FOOD SAFETY CONTROL MEASURES CAC/GL 69-2008 Validation: Obtaining evidence that a control measure or combination of control measures, if properly implemented,
More informationSCOPE OF ACCREDITATION TO ISO/IEC 17025:2005
SCOPE OF ACCREDITATION TO ISO/IEC 17025:2005 COVANCE LABORATORIES INC. 55 East Hamblin Ave. Battle Creek, MI 49017 Hollis Cloninger Phone: 608 210-5501 BIOLOGICAL Valid to: August 31, 2019 Certificate
More informationPreparation Approval Authorisation Application date. Directive Council The President
Title Proficiency Testing Reference RT-24 Revision 02 Date 2015-10-27 NOTE: The present document represent the English version of document under reference at the specified revision. In case of conflict
More informationFood Safety. Sanitation and the Value Added Farmers Market Venues. Bryan Haugen
Food Safety Sanitation and the Value Added Farmers Market Venues Bryan Haugen Environmental Public Health Specialist IV Bureau of Environmental Regulation and Licensure Department of Health and Senior
More informationISO Gestión y buenas prácticas en el sector alimentos
Labros Bouklis ISO 22000 Gestión y buenas prácticas en el sector alimentos INLAC 2008 - LABROS BOUKLIS 1 Food Safety Assurance that food will not cause harm to the consumer when it is prepared and/or eaten
More informationGLP/SC/01 Basic statistical tools for analytical chemistry (2 days)
GLP Consulting http://consultglp.com Courses on offer (See outlines below) GLP/SC/01 Basic statistical tools for analytical chemistry (2 days) GLP/SC/02 The GUM bottom-up evaluation technique of measurement
More informationOpportunities and Challenges for Dutch Processed Food Companies in India
Opportunities and Challenges for Dutch Processed Food Companies in India Zeist, 12 May 2015 Management Consulting Firm Strategy Operations Research Quick Introduction Founder & Chief Executive, Third Eyesight
More informationActivities and role of the European Union Reference Laboratory for L. monocytogenes
Activities and role of the European Union Reference Laboratory for L. monocytogenes Adrien ASSERE Deputy manager EURLs L. monocytogenes, Staphylococci, Milk & Milk Products ANSES-Laboratory for Food Safety,
More informationWhat a Preventive Controls Facility Looks Like. FSMA-HARPC vs. HACCP
What a Preventive Controls Facility Looks Like FSMA-HARPC vs. HACCP VS. COMPLIANCE WHAT S THE BEST APPROACH? CCPs HARPC GMPs GLOBAL FOOD SUPPLY THE FOOD SUPPLY NOW IS A GLOBAL ENTERPRISE! GLOBALIZATION
More informationTQCSI HACCP Code: 2017
HACCP Code: 2017 HACCP Code for Food Safety Programs HACCP CODE: 2017 published by: TQCS International Pty Ltd Head Office: 117A Tapleys Hill Road HENDON SA 5014 AUSTRALIA ph: +61 8 8347 0603 fax: +61
More informationEvent-specific Method for the Quantification of Oilseed Rape Line Ms8 Using Real-time PCR. Validation Report
EUROPEAN COMMISSION DIRECTORATE GENERAL JRC JOINT RESEARCH CENTRE INSTITUTE FOR HEALTH AND CONSUMER PROTECTION COMMUNITY REFERENCE LABORATORY FOR GM FOOD AND FEED Event-specific Method for the Quantification
More informationLaboratory Quality Assurance Manager & Laboratory Assessor RULES & HANDBOOK
EOQ Personnel Registration Scheme Laboratory Quality Assurance Manager & RULES & HANDBOOK Prepared by: Dr. Eugenia Soboleva, Quality Austria In accordance with the working group on EOQ product development
More informationAppendix F: Guidelines for Standard Method Performance Requirements
Appendix F: Guidelines for Standard Method Performance Requirements Contents Introduction to Standard Method Performance Requirements 1 Annex A: Format of a Standard Method Performance Requirement 5 Annex
More informationFood safety management systems Requirements for bodies providing audit and certification of food safety management systems
TECHNICAL SPECIFICATION ISO/TS 22003 Second edition 2013-12-15 Food safety management systems Requirements for bodies providing audit and certification of food safety management systems Systèmes de management
More informationUNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC
UNITED STATES DEPARTMENT OF AGRICULTURE FOOD SAFETY AND INSPECTION SERVICE WASHINGTON, DC FSIS NOTICE 40-12 6/4/12 FSIS VERIFICATION TESTING FOR NON-O157 SHIGA TOXIN-PRODUCING ESCHERICHIA COLI (NON-O157
More informationBIOMERIEUX. AFNOR Validation of Alternative Methods FOOD MICROBIOLOGY REPORT
accréditation Cofrac n 1-0144 portée disponible sur www.cofrac.fr BIOMERIEUX Research & Development Industry Unit Chemin de l Orme 69280 MARCY L ETOILE FRANCE AFNOR Validation of Alternative Methods FOOD
More informationThe Proposed Safe Food for Canadians Regulations (SFCR) Information Session
The Proposed Safe Food for Canadians Regulations (SFCR) Information Session 2011 Her Majesty the Queen in Right of Canada (Canadian Food Inspection Agency), all rights reserved. Use without permission
More informationRisk Management Programme Page: 1 of 8 Date: / / 1. Business Identification. 2. Operator Name, Business Address and Contact Details
Risk Management Programme Page: 1 of 8 Date: / / 1. Business Identification 1.1 Business ID: 1.2 RMP No.: 1.3 Unique Location Identifier for Dairy Business Operators: 2. Operator Name, Business Address
More informationB C ISO/IEC INTERNATIONAL STANDARD. General criteria for the operation of various types of bodies performing inspection
INTERNATIONAL STANDARD ISO/IEC 17020 First edition 1998-11-15 General criteria for the operation of various types of bodies performing inspection Critères généraux pour le fonctionnement de différents
More informationThe HPA Guidelines for Assessing the Microbiological Safety of Ready-to-eat Foods placed on the market and. Hospital Guidelines
The HPA Guidelines for Assessing the Microbiological Safety of Ready-to-eat Foods placed on the market and Hospital Guidelines HPA FW&E Microbiology Service Developing Guidelines in Partnership FSA, Defra,
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK Issue No 018 Issue date: 11 December 2017 Accredited to ISO/IEC 17021-1:2015 to provide food safety 10 A Victory Park Victory Road Derby DE24
More informationMilk quality testing and regulation
The Milk Day Trento 4th February 2015 Milk quality testing and regulation Dr. Ulrich Leist The DRRR About us The DRRR covers the following scientific sectors: Chemical testing Microbiological testing Organoleptic
More information1
ISHS III International Conference on Fresh cut Produce 15 September 2015 Corrective Action FSMA Final Rule for Preventive Controls for Human Food 1 Sept. 2015 Current Good Manufacturing Practice and Hazard
More informationAugust 2, 2005 STRATEGIC PARTNERSHIP PROGRAM AGROTERRORISM INITIATIVE
August 2, 2005 MEMORANDUM FOR AMI INSPECTION COMMITTEE FROM: SUBJECT: SKIP SEWARD STRATEGIC PARTNERSHIP PROGRAM AGROTERRORISM INITIATIVE A conference call was held today with representatives from the FBI,
More informationThe best quality assurance for meat and animal feed comes from the Netherlands
The best quality assurance for meat and animal feed comes from the Netherlands The Dutch livestock and meat sectors have a worldwide reputation to uphold as reliable suppliers of quality produce. To safeguard
More informationThe lab approval in the framework of BNN is a modular system consisting of two columns: Column A) Parameter groups, and Column B) Food groups.
Guidelines for laboratory approval by Bundesverband Naturkost Naturwaren (BNN) e.v. (Federal Association for Natural Foods and Natural Products inc. soc.) Editorial revision 01 September 2015 The results
More informationGAPS, FSMA and the Produce Rule
GAPS, FSMA and the Produce Rule Erik Schellenberg Food Safety Resource Educator February 2016 Erik Schellenberg Food Safety Resource Educator ENYCHP jk2642@cornell.edu 845-344-1234 Third Party Audits Buyer-driven
More informationListeria spp., Fostering a shift in food safety culture
Listeria spp., Fostering a shift in food safety culture Welcome! Shawn Gartside Regional Sales Manager shawn.gartside@.com Trevor Morones Lead Food Safety Consultant tmorones@controlpoint.consulting 2
More informationINSTRUCTIONS FOR FOOD SERVICE FACILITY CHANGE OF OWNERSHIP WITH NO CHANGES TO OPERATION, EQUIPMENT, OR FACILITY
INSTRUCTIONS FOR FOOD SERVICE FACILITY CHANGE OF OWNERSHIP WITH NO CHANGES TO OPERATION, EQUIPMENT, OR FACILITY Dear Prospective or New Food Service Facility Owner: Pursuant to Code of Maryland Regulation
More informationSpringfield, Illinois June 18 20, 2015
Jason Young jason.young@okstate.edu GFSI Specialist/ Quality Management Specialist Robert M. Kerr Food & Agricultural Products Center http://www.fapc.biz/ Springfield, Illinois June 18 20, 2015 Retail
More informationCERTIFICATION. Certificate No. The AOAC Research Institute hereby certifies that the performance of the test kit known as: RIDASCREEN Gliadin
CERTIFICATION AOAC Performance Tested SM Certificate No. 120601 The AOAC Research Institute hereby certifies that the performance of the test kit known as: RIDASCREEN Gliadin manufactured by R Biopharm
More informationInnovation and Trends in Consumer Marketing in Europe
Innovation and Trends in Consumer Marketing in Europe Karen Hamann The Institute for Food Studies & Agroindustrial Development IFAU, Enghave 4, DK 2960 Rungsted Kyst, DENMARK www.ifau.dk Email: karen@ifau.dk
More informationISO 22000:2005 Food safety management systems Requirements for any organization in the food chain
SESSION 7B ISO 22000:2005 Food safety management systems Requirements for any organization in the food chain Incorporating HACCP Principles 19/07/2017 ISO 22000: FSMS & HACCP Principles 1/42 WHAT IS ISO
More informationUNDERSTANDING THE FSSC FOOD SAFETY SYSTEM CERTIFICATION SCHEME
UNDERSTANDING THE FSSC 22000 FOOD SAFETY SYSTEM CERTIFICATION SCHEME A WHITE PAPER ON THE CHALLENGES, IMPACTS AND OPPORTUNITIES CONTAINED IN FSSC 22000 MAY 2012 AUTHORS Supreeya Sansawat Global Food Business
More informationMedical Device Directive
Medical Device Directive WG9 - IEC/SC 62A ISO/TC 184/SC 2 Joint Working Group 9 Saeed Zahedi 4 th of July 2012 Blatchford Copyright 2012 Commercial in confidence Definition and Requirements MDD is law,
More informationEU Document on Analytical Quality Control and Method Validation Procedures for Pesticide Residues Analysis in Food and Feed An update
EU Document on Analytical Quality Control and Method Validation Procedures for Pesticide Residues Analysis in Food and Feed An update Antonio Valverde Pesticide Residues Research Group University of Almería,
More informationDeadline for tenders: 22 September 2016
Call for tender for the validation of the Measurement Systems and the synthesis report on the measurement campaigns (one test bench and two field tests) in order to standardize an automated HCl (Hydrogen
More informationprogress in GMO analysis and presentation of the Compendium of validated reference methods
2 nd International Workshop on Harmonisation of GMO Detection and Analysis for Central and South America Merida, Mexico 2-3 March 2011 1 2009-2010 progress in GMO analysis and presentation of the Compendium
More informationBacteriological Analyses
TCR ARABIA Microbiology Services Bacteriological Analyses of Food, Water, Soil, Dairy, Cosmetics & Environmental Samples MICROBIOLOGY DEPARTMENT SERVICES Company Ltd., Microbiology Division undertakes
More informationComparison of regulatory frameworks of Austria, Germany, France, and South Tyrol for GM free labelling of food products
Final Version October 11th, 2012 Comparison of regulatory frameworks of Austria, Germany, France, and South Tyrol for GM free labelling of food products Umweltbundesamt GmbH, Dr. Helmut Gaugitsch, Dr.
More informationBIO NEWS. Food Diagnostics Special. Genomic DNA from food and feed for GMO detection / quantification and animal species differentiation
BIO NEWS Food Diagnostics Special Genomic DNA from food and feed for GMO detection / quantification and animal species differentiation NucleoSpin Food NucleoSpin Food Purification of genomic DNA from food
More informationIECEE OPERATIONAL DOCUMENT
IECEE OD-2048 Edition 1.5 2017-05-17 IECEE OPERATIONAL DOCUMENT IEC System of Conformity Assessment Schemes for Electrotechnical Equipment and Components (IECEE System) Utilization of Customers Testing
More informationSTANDARD FOR LIVE AND RAW BIVALVE MOLLUSCS CODEX STAN Adopted in Amendment: Revision: 2014 and 2015.
STANDARD FOR LIVE AND RAW BIVALVE MOLLUSCS CODEX STAN 292-2008 Adopted in 2008. Amendment: 2013. Revision: 2014 and 2015. CODEX STAN 292-2008 2 1. SCOPE This Standard applies to live bivalve molluscs and
More informationInterpretation of Microbiological Test Results. Nicola Elviss FW&E Microbiology Network June 2010
Interpretation of Microbiological Test Results Nicola Elviss FW&E Microbiology Network June 2010 PHLS Guidelines for the microbiological quality of some ready-to-eat foods at the point of sale: 1992, revised
More informationRAPID Salmonella/Agar
356-3961 356-3963 356-4705 DEFINITION RAPID Salmonella agar is a chromogenic medium used for the detection of Salmonella spp. in the analysis of food products for human, animal consumption and in environmental
More informationSchedule of Accreditation issued by United Kingdom Accreditation Service 2 Pine Trees, Chertsey Lane, Staines-upon-Thames, TW18 3HR, UK
ISO/IEC 17021-1:2015 to provide food safety management systems certification Cobra Court 1 Blackmore Road Stretford Manchester M32 0QY Contact: Mr S Stubley Tel: +44 (0)161 865 3699 Fax: +44 (0)161 865
More informationAvailable online at ScienceDirect. Procedia Engineering 132 (2015 )
Available online at www.sciencedirect.com ScienceDirect Procedia Engineering 132 (2015 ) 811 815 The Manufacturing Engineering Society International Conference, MESIC 2015 Metrological Regulations for
More informationFSSC Version 3.2 to Version 4.1 Key Changes Document
to Version 4.1 All changes from version 3.2 to version 4 are highlighted in yellow. i 3.2 Prerequisite programmes 2.1.3 Prerequisite Programs (PRP) When establishing, implementing and maintaining the Prerequisite
More informationThe new ISO/IEC 17025:2017
The new ISO/IEC 17025:2017 By Dr. George Anastasopoulos Director, Conformity assessment, IAS Email: ganastasopoulos@iasonline.org Introduction - Background information ISO/IEC 17025 was first issued in
More informationCertified Non-GMO by AGW
Certified Non-GMO by AGW The following Certified Non-GMO by AGW standards are an optional addition to the individual Animal Welfare Approved by AGW livestock standards. In order for products to be approved
More information3M Microbiology. Food safety. maximized. Safety. Processing
3M Microbiology Food safety Processing maximized Safety Food Safety Maximized The importance of food safety Producing safe and healthy food is critical to the success of one of the largest industries worldwide.
More informationNordVal International. c/o Norwegian Veterinary Institute PB 750 Sentrum, N-0106 Oslo, Norway RAPID L. mono
NordVal International / NMKL c/o Norwegian Veterinary Institute PB 75 Sentrum, N-6 Oslo, Norway www.nmkl.org Issued for: RAPID L. mono NordVal No: First approval date: November 5 Extension date: December
More informationThe Role of National Food Safety Agencies in the Food Supply Chain
The Role of National Food Safety Agencies in the Food Supply Chain Nuri Gras Technical Director Food Intelligence Net Chile FAO/IAEA Satellite event on : Food Control Systems and the Role of the Different
More informationShriram Institute for Industrial Research - An Innovative Research Centre for Micro & Macro Evaluation
Shriram Institute for Industrial Research - An Innovative Research Centre for Micro & Macro Evaluation Dr. K. J. Balasubramani Divisional Head Shriram Institute for Industrial Research Bangalore SHRIRAM
More informationFood waste and date labelling. - issues affecting the durability
Food waste and date labelling - issues affecting the durability Optimise food labelling to minimise food waste in the Nordic countries without challenging food safety Requires interdisciplinary approaches!
More informationProduction of Food Packaging SQF Code Modules 2 and 13 Food Sector Categories 27
Production of Food Packaging SQF Code Modules 2 and 13 Food Sector Categories 27 A HACCP-Based Supplier Assurance Code for the Food Industry Edition 7.2 July 2014 2014 Safe Quality Food Institute 2345
More informationRetail Food Establishment Inspection Report LA CROSSE, WI 54601
LA CROSSE COUNTY HEALTH DEPARTMENT Environmental Health Division STATE OF WISCONSIN s. 97.30, s. 254.61, Subchapter VII, Wis. Stats. Retail Food Establishment Inspection Report Establishment Information
More informationNF VALIDATION Validation study according to the EN ISO standard. Summary report
ACCREDITATION N 1-0144 PORTEE DISPONIBLE SUR WWW.COFRAC.FR 3M Boulevard de l Oise F-95029 CERGY PONTOISE NF VALIDATION Validation study according to the EN ISO 16140 standard Summary report EN ISO 16140
More information